Company cites material fatigue issue tied to resin defect
BD and its Bard subsidiary have issued a warning regarding certain PowerPICC intravascular catheters, citing material fatigue concerns that may lead to cracking. The FDA shared the alert, which affects 4 Fr. single lumen models, including both SOLO and non-SOLO versions.
These catheters, used for IV therapy, power injection of contrast media, and central venous pressure monitoring, have shown transverse or circumferential cracks due to a material resin defect during manufacturing.
Key risks include:
- Air or foreign body embolism
- Bleeding or infection
- Phlebitis, extravasation, and therapy disruption
BD has reported 10 serious injuries linked to the defect. While unused devices should be destroyed immediately, BD advises not to explant catheters already in use unless there is visible damage. The company also recommends:
- Switching to adhesive-backed securement systems
- Using securement devices sized to the catheter’s taper region
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